Postprandial Regulation of Bone Perfusion in Healthy Individuals
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-50
SponsorUniversity of Copenhagen
About this trial
The goal of this clinical trial is to learn whether certain natural hormones - Glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-2, (GLP-2), and amylin - affect blood flow to the bones.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 25-50 years.
BMI between 18.5-30 kg/m2.
Normal gait.
Premenopausal (if female).
Disqualifiers
Bone disease incl. confirmed osteopenia.
Fracture within the last 6 months at the time of inclusion.
Amputation or congenital defect of extremities.
HbA1c>41.9 mmol/mol and/or diagnosed type 1 or type 2 diabetes.
Trial design
Design model
Crossover
Treatments tested in this trial
isotonic saline infusion
Other interventionPlacebo infusion for comparison of active hormone
Infusion of GIP(1-42)
Other interventionStudy tool
Infusion of GLP-2(1-33)
Other interventionStudy tool
Infusion of pramlintide
Other interventionStudy tool
Treatment groups
15 Participants
are divided into 4 treatment groupsGroup A: Isotonic salinePlacebo comparator 1 intervention
Group B: GIP(1-42)Active comparator 1 intervention
Group C: GLP-2(1-33)Active comparator 1 intervention
Group D: PramlintideActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Median Ki in the Femur
Kinetic modelling
Time frame
90 minutesSecondary outcomes
1
Median Ki in the lumbar spine
Kinetic modelling
Time frame
90 minutes2
Ki in other bones.
Kinetic modelling
Time frame
90 minutes3
Bone perfusion (K1)
Kinetic modelling
Time frame
90 minutes4
Bone incorporation fraction (K3/K3+K2)
Kinetic modelling
Time frame
90 minutes.Other outcomes
1
Mean and max SUV (standardized uptake values)
Time frame
90 minutes.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Copenhagen
Lead sponsor
Rigshospitalet, Denmark
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: